MAUDE Adverse Event Report: AMNISURE INTERNATIONAL, LLC AMNISURE; RAPID FETAL MEMBRANES RUPTURE TEST

Model Number FMRT-1

Device Problem False Negative Result (1225)

Patient Problem Death, Intrauterine Fetal (1855)

Event Type  Death  

Event Description

Adverse event reported by distributor in (b)(6) on (b)(6) 2015.Approximately two months prior to reporting this adverse event, a patient arrived at her ob/gyn complaining of discharge.The patient was at a gestational age of (b)(6) weeks and was carrying twins.An amnisure test was performed and the result was negative.The patient was sent home.The patient returned to the hospital 5 days later complaining of continued discharge.Another amnisure test was performed and the result was again negative.A sonogram was performed and showed a very low afi.A cesarean section was then performed and both fetus' were deceased.The physician was not claiming that there was a false negative result with this incident.The physician stated that there was uncertainty as to whether the patient was ruptured and the low afi may have been due to other clinical conditions.

Manufacturer Narrative

The company is unable to obtain information to further investigate this event due to a holiday in (b)(6).The company is submitting this mdr in compliance with 21 cfr part 803.The company will supplement this mdr with additional information, as necessary.Our preliminary investigation has identified the following: a) the intended use of the amnisure rom test, as written in the package insert, indicates that the test is an aid in the detection of rupture of fetal membranes (rom) in pregnant women.As a diagnostic aid, there is an expectation that patient care is based on a multitude of factors/tests/analyses.In this case, an initial ultrasound would have been useful as an additional tool in determining rom status and clinical actions.B) the attending physician was unable to confirm that the patient had been leaking amniotic fluid.Due to the patient's condition there may have been other clinical factors that attributed to her low amniotic fluid level, thus amnisure would have provided correct results.C) the company performed testing on retain samples for the lots implicated and all results passed specifications.Additionally, batch records were reviewed and all testing passed specifications with no deviations noted.

• Brand Name: AMNISURE
• Type of Device: RAPID FETAL MEMBRANES RUPTURE TEST
• Manufacturer (Section D): AMNISURE INTERNATIONAL, LLC; 24 school street, 6th floor; boston MA 02108
• Manufacturer Contact: donna sowers ; 19300 germantown road; germantown, MD 20874 ; 2406867876
• MDR Report Key: 4651981
• MDR Text Key: 16880627
• Report Number: 3005345832-2015-00002
• Device Sequence Number: 1
• Product Code: NQM
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K081767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: FMRT-1
• Device Catalogue Number: FMRT-1-10-ML-RT
• Device Lot Number: A354525, A355744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death